Senior Associate ScientistUnited States - California - Santa MonicaQualityRegular
Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Join us in our mission!
Kite is seeking a highly motivated individual to join Kite as a Senior Associate Scientist to provide Quality Control oversight of Global Raw Materials and Reagents Center of Excellence.
Responsibilities include (but not limited to):
- Develop and validate GMP test methods for raw materials. Author and review SOPs, qualification/validation protocols, and reports. Manage method development at contract labs.
- Conduct investigations regarding out of specifications (OOS) results. Address and manage deviations related to analytical procedures.
- Manage creation and revision of raw materials specifications.
- Monitor and trend data, complete routine record review of test data and related documents for raw materials release.
- Maintain, calibrate and operate equipment and instruments supporting Raw Material Testing labs
- Work with internal and external resources to maintain lab in an optimal state.
- Work independently with minimal supervision and ability to identify, effectively communicate, and troubleshoot issues.
- Provide updates at daily and weekly meetings.
- Perform other duties, including QC inspections and routine testing of raw materials
- Represent the Global Raw Materials and Reagents Center of Excellence’s short and long term goals in cross functional task forces and collaborative efforts
- MA/MS in Chemistry or Biochemistry with 4+ years’ hands-on laboratory experience in a biotech/biopharmaceutical setting OR
- BA/BS Chemistry or Biochemistry with 6+ years’ hands-on laboratory experience in a biotech/biopharmaceutical setting OR
- High School diploma with 10+ years’ hands-on laboratory experience in a biotech/biopharmaceutical setting
- Experience in US and International compendial methods (Visual Inspection, pH, osmolality, conductivity, endotoxin, etc.), ELISA, Gel/Western Blot, FT-IR, HPLC, PCR for materials, buffers, and reagents
- Experience with biochemical and biophysical analytical methods: pH, Osmolality, Conductivity, Visual Inspection, Protein assays, FT-IR, PCR, etc.
- Experience operating in a GMP environment
- Experience leading method development, method validation, investigations, deviations, and CAPAs
- Exceptional oral and written communication skills
- Ability to work independently, prioritize projects, and thrive in a dynamic environment
- Excellent interpersonal, collaborative, and time management skills
- Understanding of global compliance and guidance for GMP manufacturing and raw materials
- Experience in managing cross-functional projects is a plus
- Experience with statistical sampling methods (WHO guidelines, ANSI, etc)
- Technical writing experience in quality records